Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin

Dentin Caries Clinical Trial

Official title:

Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145102
• Other study ID #: REC18-076
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: January 2021
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study will be performed to evaluate:

1. The remineralizing effect of natural materials versus synthetic materials on deep carious dentin after selective caries removal.

2. The antibacterial effect of natural materials versus synthetic materials on deep carious dentin.

Description:

This study will be conducted on 64 teeth selected from patients according to inclusion and exclusion criteria. They will be selected from the dental clinic in faculty of dental medicine, Al-Azhar University. The procedure will be explained and written informed consent will be obtained from each patient. The possible discomforts, risks, and benefits will be fully explained to the patients. Ethical committee approval will be obtained.

Protocol of caries removal will be removed Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin will be then excavated, leaving the last carious affected dentin layer.

Sample grouping:

The patients will be randomly assigned into four main groups according to the material used (16 for each) then each group will be subdivided into two subgroups (n=8) according to time of treatment (B1) after one month,(B2) after three month.

A1: cavities will be treated by propolis extract then sealed directly by temporary conventional glass ionomer.

A2: cavities will be treated by hesperidin then sealed directly by temporary conventional glass ionomer.

A3: cavities will be treated with Silver diamine fluoride then sealed directly by temporary conventional glass ionomer.

A4: cavities will be sealed directly by temporary restorative material (conventional glass ionomer) without any treatment.

Evaluation of the microbiological effect Dentine samples will be collected from the base of the cavity using sterile spoon excavator from the four groups for baseline bacteriological assessment immediately after excavation, then another sample will be taken after one month for each subgroup (B1)and three months of treatment for each subgroup (B2).

Evaluation of the remineralization effect Each group will be assessed radiographically immediately at base line (B0), after one month (B1) and three months (B2) to evaluate the dentin remineralization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 20, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Subject must have active deep carious lesion.

• clinical and radiographic examinations of carious lesions.

Exclusion Criteria:

• Teeth with pulpal involvement

• Teeth with abscess

• Teeth with pain or swelling

• Teeth with developmental disorders

• Teeth with adjacent soft tissue lesions

• patients with systemic illness will be excluded

Related Conditions & MeSH terms

• Dental Caries
• Dentin Caries

Intervention

Other:
• hesperidine
used for antibacterial and reminerlization assesment
• propolis
used for antibacterial and reminerlization assesment
• silver diamine fluoride
used for antibacterial and reminerlization assesment

Locations

Country	Name	City	State
Egypt	Alazher university	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin	antibacterial effect will be evaluated by bacterial count at base line and after three months reminerliazation effect will be evaluated by radiographes	antibacterial and reminerlizing effect will be evaluated after three monthes